BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 10022503 · Received May 4, 2020

    Report

    Report Number
    1920898-2020-00469
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 17, 2020
    Report Date
    May 29, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6) 2020. H.6. INVESTIGATION: CUSTOMER RETURNED (4) LOOSE 3/10CC SYRINGES. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED. ALL SYRINGES WERE RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. ALSO, 2 OUT OF 4 SAMPLES EXHIBITED A BENT BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252570. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED FOR HIGH SHIELD PULL. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.3ML, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. DHR, L2L DISPATCHES, AND LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THESE DEFECTS WERE FOUND. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#1122103 WAS INITIATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 6MM WHOLE UNIT 10 BAG HAD THE NEEDLE SEPARATE FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD WHEN HE REMOVED THE SHIELD. ISSUE INVOLVES (2) SYRINGES."

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LEVEL B INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 6TH RELATED COMPLAINT FOR NEEDLE HUB SEPARATES ON LOT # 9252570. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252570. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200845676, 200845565] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS [200845567, 200845495] NOTED FOR HIGH SHIELD PULL. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG HAD THE NEEDLE SEPARATE FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD WHEN HE REMOVED THE SHIELD. ISSUE INVOLVES (2) SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483555 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 9252570 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other